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Quality & Regulatory Leader - Medical Implants

Bangalore Urban Permanent View Job Description
As the Quality & Regulatory Leader, you will be instrumental in establishing and managing the Quality & Regulatory Affairs function for new manufacturing plant in implant space in India. This role offers the rare opportunity to build processes, systems, and a team from the ground up and liase with our international team.
  • Opportunity to lead QA RA for medical implants greenfield project
  • Set up and maintain the Quality Management System in ISO 13485

About Our Client

Global medical devices client in the space of orthopedic implants

Job Description

  • Regulatory Affairs:
    • Lead interactions with Indian health authorities (CDSCO) for the registration and continued compliance of our implants and instruments.
    • Oversee the regulatory process for the new facility certification.
  • Quality System & Compliance:
    • Set up and maintain the Quality Management System in alignment with ISO 13485 and corporate standards.
    • Ensure compliance with national and international medical device regulations.
  • Process & Equipment Qualification:
    • Coordinate the qualification of industrial processes and validation of new equipment for production.
  • Clinical Affairs:
    • Manage and coordinate clinical investigations for products, in collaboration with corporate teams.
  • Team Development:
    • Recruit, train, and manage a growing quality and regulatory team to support operations and scale with business needs.

The Successful Applicant

  • Experience:
    • 8+ years in quality and/or regulatory roles within the medical device industry, ideally with Class II or III implants.
    • Prior experience in greenfield or startup manufacturing environments is a strong plus.
  • Skills & Attributes:
    • Deep understanding of ISO 13485, CDSCO regulatory frameworks, and international medical device compliance.
    • Hands-on leadership style with a willingness to build and scale operations from scratch.
    • Strong communicator with cross-cultural collaboration skills.
    • Passionate about quality and patient safety, with a mindset for continuous improvement.

What's on Offer

Opportunity to work directly with the international counterpart

Lead QA RA for a greenfield project

Quote job ref
JN-052025-6747499

Job summary

Function
Healthcare & Life Sciences
Sub Sector
Manufacturing / Quality
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Bangalore Urban
Job Type
Permanent
Job Reference
JN-052025-6747499

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.

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